Ursodeoxycholic acid composition and its preparation method, application and preparation

Abstract

The present invention provides an ursodeoxycholic acid composition and a preparation method, application and preparation thereof, belonging to the technical field of pharmaceutical preparations. The ursodeoxycholic acid composition comprises the following components by weight: 250 parts of ursodeoxycholic acid, 39-59 parts of corn starch, 18-28 parts of xylitol, 4-7 parts of colloidal silicon dioxide, 2-4 parts of magnesium stearate and 115-130 parts of purified water. The starch and xylitol of the present invention are scientifically compounded to play a synergistic role, and further through strict process research, the production process is simple, and on the basis of ensuring the content of effective ingredients, the product quality is stable, and the dissolution behavior is equivalent to that of the original drug.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to an ursodeoxycholic acid composition and a preparation method, application and preparation thereof. Background Art

[0002] Ursodeoxycholic acid can promote the hydrolysis of fat and fatty acids, inhibit the synthesis of liver cholesterol, increase the activity of liver catalase, promote the accumulation of liver glycogen, improve the liver's anti-toxic and detoxification capabilities, and reduce the concentration of triglycerides in the liver and serum; it can significantly reduce the activity of cholesterol synthase HMG-CoA reductase, increase the activity of cholesterol metabolic enzyme 7α hydroxylase, thereby reducing the gram molecular weight of cholesterol and cholesterol esters in bile and the saturation index of cholesterol, which is beneficial to the gradual dissolution of cholesterol in stones. It can be used as the first choice drug for patients with primary biliary cirrhosis, and the adverse reaction rate is much lower than that of similar products.

[0003] However, the original drug of ursodeoxycholic acid capsule is expensive, so it is urgent to develop new ursodeoxycholic acid preparations.

[0004] Chinese invention patent CN109568288A discloses an ursodeoxycholic acid capsule and a preparation method thereof, wherein the raw materials include, by weight: 3-9 parts of ursodeoxycholic acid, 0.01-4 parts of pregelatinized starch, 0.02-4 parts of starch, 0.1-2 parts of starch, 0.1-0.2 parts of magnesium stearate, 0.05-0.5 parts of colloidal silicon dioxide and 0.05-1 parts of hydroxypropyl methylcellulose, wherein the ursodeoxycholic acid is micronized and has a particle size D90 < 40 μm. The ursodeoxycholic acid used in the patent is micronized, and the particle size control is relatively complicated and has high requirements for equipment. The micronized API has strong agglomeration and adhesion, and it is difficult to avoid the API from adhering to the production equipment.

[0005] Chinese invention patent CN116350599A discloses an ursodeoxycholic acid capsule and a preparation method thereof, comprising the following steps: mixing ursodeoxycholic acid raw material and diluent, crushing; slurry preparation: heating water, keeping warm, adding starch, stirring, and obtaining starch slurry; premixing: adding the mixed material and the remaining starch in the prescription amount to a wet granulator, and premixing; granulation: adding water to the surface of the material, and performing the first granulation; adding starch slurry, and performing the second granulation; adding water, and performing the third granulation; discharging, granulation, and obtaining wet granules; drying: drying the wet granules; granulation and total mixing: mixing the dried granules with colloidal silicon dioxide and magnesium stearate; and capsule filling. The patented granulation process is complex, requiring a three-step granulation process, with cumbersome steps, high requirements on equipment, and low production efficiency.

[0006] Given that the prescription and preparation process of the original drug cannot be fully obtained and the original drug is expensive, the preparation process of ursodeoxycholic acid capsules in the existing technology is relatively complicated, and there is a gap between the in vitro dissolution behavior and the original drug. Therefore, there is an urgent need to develop an ursodeoxycholic acid preparation with a simple process, high production efficiency, and dissolution behavior equivalent to that of the original drug. Summary of the invention

[0007] In order to simplify the production process of ursodeoxycholic acid preparations in the prior art, ensure the stability of product quality, and maintain the dissolution behavior equivalent to that of the original drug, the object of the present invention is to provide an ursodeoxycholic acid composition and a preparation method, application and preparation thereof.

[0008] In order to achieve the above object, the present invention adopts the following technical solutions:

[0009] The invention provides an ursodeoxycholic acid composition, which comprises the following components by weight: 250 parts of ursodeoxycholic acid, 39-59 parts of corn starch, 18-28 parts of xylitol, 4-7 parts of colloidal silicon dioxide, 2-4 parts of magnesium stearate and 115-130 parts of purified water.

[0010] Furthermore, the ursodeoxycholic acid composition comprises the following ingredients, by weight: 250 parts of ursodeoxycholic acid, 47.5 parts of corn starch, 25 parts of xylitol, 5 parts of colloidal silicon dioxide, 2 parts of magnesium stearate and 125 parts of purified water.

[0011] The present invention also provides a method for preparing the ursodeoxycholic acid composition, comprising the following steps:

[0012] S1. dissolving part of corn starch in part of purified water at a constant temperature to obtain a starch slurry; the part of purified water has been preheated to a fixed temperature;

[0013] S2, mixing ursodeoxycholic acid, xylitol and remaining corn starch, adding remaining purified water, and then adding the starch slurry obtained in step S1 to granulate to obtain wet granules;

[0014] S3, sieving and drying the wet granules obtained in step S2 to obtain dry granules, alternately sieving and granulating the dry granules and colloidal silicon dioxide, and then mixing with magnesium stearate to obtain an ursodeoxycholic acid composition.

[0015] In some specific embodiments, the method for preparing the ursodeoxycholic acid composition comprises the following steps:

[0016] S1. Dissolving part of corn starch in part of purified water at a constant temperature within a fixed time (30 min) to obtain a starch slurry, wherein the weight portion of the corn starch is 7.5-12 parts, the mass concentration of the starch slurry is 8-10%, and the part of purified water has been preheated to a fixed temperature;

[0017] S2, placing ursodeoxycholic acid, xylitol and the remaining corn starch in a wet granulator and mixing them, adding the remaining purified water, and then adding the starch slurry described in step S1 to granulate to obtain wet granules;

[0018] S3, passing the wet granules through a sieve, collecting the sieved granules and drying them until the moisture content is less than 2 wt % to obtain dry granules, alternately passing the dry granules and colloidal silicon dioxide through a sieve and granulating, and then mixing with magnesium stearate to obtain the ursodeoxycholic acid composition.

[0019] Furthermore, in the granulation in step S2, the stirring speed is 170-195 rpm, the cutting speed is 2000-2400 rpm, the water inlet rate is 0.5-1 L / s, and the temperature is 20-30°C; the starch slurry inlet rate is 1.7-6 L / s.

[0020] Furthermore, the particle size of the ursodeoxycholic acid in step S2 is D90 of 130-180 μm and D50 of 40-50 μm.

[0021] Furthermore, the mass ratio of the remaining corn starch and xylitol in step S2 is (1.2-1.8):1.

[0022] Furthermore, the mass ratio of the remaining corn starch to xylitol in step S2 is 1.5:1.

[0023] Furthermore, the constant temperature and the fixed temperature in step S1 are 80-90°C.

[0024] Furthermore, the drying temperature in step S3 is 50-70°C.

[0025] Furthermore, in step S3, the aperture size of the sieve through which the wet particles pass is 5×5 mm-8×8 mm, and the aperture size of the sieve through which the dry particles and colloidal silicon dioxide pass is 1.0-3.0 mm.

[0026] The present invention also provides application of the ursodeoxycholic acid composition in preparing an ursodeoxycholic acid preparation.

[0027] Furthermore, the preparation includes granules, tablets or capsules.

[0028] The invention also provides an ursodeoxycholic acid capsule, which is prepared from the ursodeoxycholic acid composition.

[0029] Furthermore, the ursodeoxycholic acid capsules include 1 part by weight of hollow capsules.

[0030] Furthermore, the hollow capsule is a gelatin hollow capsule.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] The ursodeoxycholic acid of the invention is obtained by mechanical pulverization and does not need to be micronized, which can effectively avoid the strong agglomeration and adhesion of the micronized raw material medicine and avoid the adhesion of the raw material medicine on the production equipment.

[0033] The invention has undergone rigorous formula and process research, has a simple production process, and is compounded with xylitol and starch in a specific mass ratio to work synergistically. On the basis of ensuring the content of effective ingredients, the product quality is stable and is equivalent to the dissolution behavior of the original drug. DETAILED DESCRIPTION

[0034] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0035] Before further describing the specific embodiments of the present invention, it should be understood that the scope of protection of the present invention is not limited to the specific embodiments described below; it should also be understood that the terms used in the examples of the present invention are for describing specific embodiments rather than for limiting the scope of protection of the present invention.

[0036] When the embodiment gives a numerical range, it should be understood that, unless otherwise specified in the present invention, the two endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the present invention belongs.

[0037] The present invention does not limit the sources of the raw materials used. Unless otherwise specified, the raw materials used in the present invention are common commercial products in the technical field.

[0038] Example 1

[0039] An ursodeoxycholic acid composition is prepared from the following ingredients by weight: 250 parts of ursodeoxycholic acid, 47.5 parts of corn starch, 25 parts of xylitol, 5 parts of colloidal silicon dioxide, 2 parts of magnesium stearate and 125 parts of purified water.

[0040] The preparation method of the ursodeoxycholic acid composition comprises the following steps:

[0041] S1. Dissolve 10 parts of corn starch in 100 parts of purified water at 80° C. at 80° C. within 30 minutes to obtain a starch slurry;

[0042] S2, placing 250 parts of ursodeoxycholic acid, 25 parts of xylitol and 37.5 parts of corn starch in a wet granulator and mixing them, adding 25 parts of purified water, and then adding the starch slurry described in step S1 to granulate to obtain wet granules;

[0043] S3, passing the wet granules through a sieve, collecting the sieved granules and drying them at 60° C. until the moisture content is less than 2 wt % to obtain dry granules, alternately passing the dry granules and colloidal silicon dioxide through a sieve and granulating, and then mixing with magnesium stearate to obtain the ursodeoxycholic acid composition;

[0044] In the granulation in step S2, the stirring speed is 175 rpm, the cutting speed is 2200 rpm, the water inlet rate is 0.8 L / s, the temperature is 25° C., and the starch slurry inlet rate is 3 L / s;

[0045] The particle size of ursodeoxycholic acid described in step S2 is 150 μm in D90 and 50 μm in D50;

[0046] In step S3, the aperture size of the sieve through which the wet particles pass is 7×7 mm, and the aperture size of the sieve through which the dry particles and colloidal silicon dioxide pass is 2.0 mm.

[0047] The preparation method of the ursodeoxycholic acid capsules comprises the following steps:

[0048] The ursodeoxycholic acid composition is filled into 1 part by weight of a gelatin hollow capsule to obtain the ursodeoxycholic acid capsule.

[0049] Example 2

[0050] An ursodeoxycholic acid composition is prepared from the following ingredients by weight: 250 parts of ursodeoxycholic acid, 39 parts of corn starch, 18 parts of xylitol, 4 parts of colloidal silicon dioxide, 3 parts of magnesium stearate and 115 parts of purified water.

[0051] The preparation method of the ursodeoxycholic acid composition comprises the following steps:

[0052] S1. Dissolve 7.5 parts of corn starch in 93 parts of purified water at 80° C. at 80° C. within 30 minutes to obtain a starch slurry;

[0053] S2, placing 250 parts of ursodeoxycholic acid, 18 parts of xylitol and 31.5 parts of corn starch in a wet granulator and mixing them, adding 22 parts of purified water, and then adding the starch slurry described in step S1 to granulate to obtain wet granules;

[0054] S3, passing the wet granules through a sieve, collecting the sieved granules and drying them at 60° C. until the moisture content is less than 2 wt % to obtain dry granules, alternately passing the dry granules and colloidal silicon dioxide through a sieve and granulating, and then mixing with magnesium stearate to obtain the ursodeoxycholic acid composition;

[0055] In the granulation in step S2, the stirring speed is 175 rpm, the cutting speed is 2200 rpm, the water inlet rate is 0.8 L / s, the temperature is 25° C., and the starch slurry inlet rate is 3 L / s;

[0056] The particle size of ursodeoxycholic acid described in step S2 is 150 μm in D90 and 50 μm in D50;

[0057] In step S3, the aperture size of the sieve through which the wet particles pass is 7×7 mm, and the aperture size of the sieve through which the dry particles and colloidal silicon dioxide pass is 2.0 mm.

[0058] The preparation method of the ursodeoxycholic acid capsules comprises the following steps:

[0059] The ursodeoxycholic acid composition is filled into 1 part by weight of a gelatin hollow capsule to obtain the ursodeoxycholic acid capsule.

[0060] Example 3

[0061] An ursodeoxycholic acid composition is prepared from the following ingredients by weight: 250 parts of ursodeoxycholic acid, 59 parts of corn starch, 28 parts of xylitol, 7 parts of colloidal silicon dioxide, 4 parts of magnesium stearate and 130 parts of purified water.

[0062] The preparation method of the ursodeoxycholic acid composition comprises the following steps:

[0063] S1. Dissolve 10 parts of corn starch in 100 parts of purified water at 80° C. at 80° C. within 30 minutes to obtain a starch slurry;

[0064] S2, placing 250 parts of ursodeoxycholic acid, 28 parts of xylitol and 49 parts of corn starch in a wet granulator and mixing them, adding 40 parts of purified water, and then adding the starch slurry described in step S1 to granulate to obtain wet granules;

[0065] S3, passing the wet granules through a sieve, collecting the sieved granules and drying them at 60° C. until the moisture content is less than 2 wt % to obtain dry granules, alternately passing the dry granules and colloidal silicon dioxide through a sieve and granulating, and then mixing with magnesium stearate to obtain the ursodeoxycholic acid composition;

[0066] In the granulation in step S2, the stirring speed is 175 rpm, the cutting speed is 2200 rpm, the water inlet rate is 0.8 L / s, the temperature is 25° C., and the starch slurry inlet rate is 3 L / s;

[0067] The particle size of ursodeoxycholic acid described in step S2 is 150 μm in D90 and 50 μm in D50;

[0068] In step S3, the aperture size of the sieve through which the wet particles pass is 7×7 mm, and the aperture size of the sieve through which the dry particles and colloidal silicon dioxide pass is 2.0 mm.

[0069] The preparation method of the ursodeoxycholic acid capsules comprises the following steps:

[0070] The ursodeoxycholic acid composition is filled into 1 part by weight of a gelatin hollow capsule to obtain the ursodeoxycholic acid capsule.

[0071] Example 4

[0072] An ursodeoxycholic acid composition is prepared from the following ingredients by weight: 250 parts of ursodeoxycholic acid, 47.5 parts of corn starch, 25 parts of xylitol, 5 parts of colloidal silicon dioxide, 2 parts of magnesium stearate and 125 parts of purified water.

[0073] The preparation method of the ursodeoxycholic acid composition comprises the following steps:

[0074] S1. Dissolve 9 parts of corn starch in 100 parts of purified water at 90° C. at 90° C. within 30 minutes to obtain a starch slurry;

[0075] S2, placing 250 parts of ursodeoxycholic acid, 25 parts of xylitol and 38.5 parts of corn starch in a wet granulator and mixing them, adding 25 parts of purified water, and then adding the starch slurry described in step S1 to granulate to obtain wet granules;

[0076] S3, passing the wet granules through a sieve, collecting the sieved granules and drying them at 60° C. until the moisture content is less than 2 wt % to obtain dry granules, alternately passing the dry granules and colloidal silicon dioxide through a sieve and granulating, and then mixing with magnesium stearate to obtain the ursodeoxycholic acid composition;

[0077] In the granulation in step S2, the stirring speed is 195 rpm, the cutting speed is 2000 rpm, the water inlet rate is 1 L / s, the temperature is 30° C., and the starch slurry inlet rate is 1.7 L / s;

[0078] The particle size of ursodeoxycholic acid described in step S2 is 180 μm in D90 and 40 μm in D50;

[0079] In step S3, the aperture size of the sieve through which the wet particles pass is 5×5 mm, and the aperture size of the sieve through which the dry particles and colloidal silicon dioxide pass is 3.0 mm.

[0080] The preparation method of the ursodeoxycholic acid capsules comprises the following steps:

[0081] The ursodeoxycholic acid composition is filled into 1 part by weight of a gelatin hollow capsule to obtain the ursodeoxycholic acid capsule.

[0082] Example 5

[0083] An ursodeoxycholic acid composition is prepared from the following ingredients by weight: 250 parts of ursodeoxycholic acid, 47.5 parts of corn starch, 25 parts of xylitol, 5 parts of colloidal silicon dioxide, 2 parts of magnesium stearate and 125 parts of purified water.

[0084] The preparation method of the ursodeoxycholic acid composition comprises the following steps:

[0085] S1. Dissolve 10 parts of corn starch in 100 parts of purified water at 85° C. at 85° C. within 30 minutes to obtain a starch slurry;

[0086] S2, placing 250 parts of ursodeoxycholic acid, 25 parts of xylitol and 37.5 parts of corn starch in a wet granulator and mixing them, adding 25 parts of purified water, and then adding the starch slurry described in step S1 to granulate to obtain wet granules;

[0087] S3, passing the wet granules through a sieve, collecting the sieved granules and drying them at 70° C. until the moisture content is less than 2 wt % to obtain dry granules, alternately passing the dry granules and colloidal silicon dioxide through a sieve and granulating, and then mixing with magnesium stearate to obtain the ursodeoxycholic acid composition;

[0088] In the granulation in step S2, the stirring speed is 170 rpm, the cutting speed is 2400 rpm, the water inlet rate is 0.5 L / s, the temperature is 20° C., and the starch slurry inlet rate is 6 L / s;

[0089] The particle size of ursodeoxycholic acid described in step S2 is 130 μm in D90 and 45 μm in D50;

[0090] In step S3, the aperture size of the sieve through which the wet particles pass is 8×8 mm, and the aperture size of the sieve through which the dry particles and colloidal silicon dioxide pass is 1.0 mm.

[0091] The preparation method of the ursodeoxycholic acid capsules comprises the following steps:

[0092] The ursodeoxycholic acid composition is filled into 1 part by weight of a gelatin hollow capsule to obtain the ursodeoxycholic acid capsule.

[0093] Comparative Example 1

[0094] The only difference between this comparative example and Example 1 is that the particle size of ursodeoxycholic acid, D50, is 30 μm and D90 is 100 μm.

[0095] Comparative Example 2

[0096] The only difference between this comparative example and Example 1 is that the particle size of ursodeoxycholic acid, D50, is 70 μm, and D90 is greater than 220 μm.

[0097] Comparative Example 3

[0098] The difference between this comparative example and Example 1 is that the wet granulation process is different. Specifically, the granulation temperature in step S2 is 35° C. and the water inlet rate is 1.3 L / s.

[0099] Comparative Example 4

[0100] The difference between this comparative example and Example 1 is that the wet granulation process is different. Specifically, the rate of entry of the starch slurry is 0.5 L / s.

[0101] Comparative Example 5

[0102] The difference between this comparative example and Example 1 is that the wet granulation process is different. Specifically, the starch slurry entry rate is 7 L / s.

[0103] Comparative Example 6

[0104] The only difference between this comparative example and Example 1 is that in step S2, no starch is used, and only xylitol is used, and the weight portion of xylitol is 62.5 parts.

[0105] Comparative Example 7

[0106] The difference between this comparative example and Example 1 is that the mass ratio of the remaining corn starch to xylitol in step S2 is 1:1, wherein the weight portion of the remaining corn starch is 31.25 parts, and the weight portion of xylitol is 31.25 parts.

[0107] Comparative Example 8

[0108] Ursodeoxycholic acid capsules prepared in Example 2 of CN11149433A were used.

[0109] Comparative Example 9

[0110] Original formulation: Urosofur, batch number: 18B01832L.

[0111] Effect performance test

[0112] 1. In vitro dissolution test

[0113] Ursofara is a reference preparation. Twelve capsules are randomly selected from each example or comparative example. The dissolution rates of the ursodeoxycholic acid capsules of the example and the comparative example are measured in a phosphate buffer solution of pH=6.8 and a phosphate buffer solution of pH=7.5 at 37±0.5°C by a conventional paddle method at 75rpm. The similarity is evaluated by the dissolution curve similarity factor f2. When the f2 value is between 50 and 100, it indicates that the cumulative dissolution amounts of the two preparations are similar.

[0114] The sampling time points of the pH=6.8 dissolution curve are 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, and 240 min.

[0115] The sampling time points for the pH=7.5 dissolution curve were 5, 10, 15, 20, 30, 45, 60, 90, and 120 min.

[0116] Preparation of pH = 6.8 phosphate buffer solution: Take 250mL 0.2mol / L potassium dihydrogen phosphate solution and mix it with 112.0mL 0.2mol / L sodium hydroxide solution, then add water to dilute to 1000mL, mix well, and adjust the pH to 6.8 with 0.2mol / L sodium hydroxide solution.

[0117] Preparation of pH = 7.5 phosphate buffer solution: Take 250mL 0.2mol / L potassium dihydrogen phosphate solution and mix it with 195.5mL 0.2mol / L sodium hydroxide solution, then add water to dilute to 1000mL, mix well, and adjust the pH to 7.5 with 0.2mol / L sodium hydroxide solution.

[0118] Dissolution apparatus: American Hanson Research Version Elite8 drug dissolution apparatus.

[0119] Table 1 Dissolution rate test results of ursodeoxycholic acid capsules (pH = 6.8)

[0120]

[0121]

[0122] Note: The time points selected for f2 are 10min, 15min, 20min, 30min, 45min, 60min, 90min, 120min, 180min and 240min.

[0123] Table 2 Dissolution rate test results of ursodeoxycholic acid capsules (pH = 7.5)

[0124]

[0125] Note: The time points selected for f2 are 5min, 10min, 15min, 20min, 30min and 45min.

[0126] As shown in the results of Table 1-2, the cumulative dissolution of Examples 1-5 and Comparative Example 8 is similar to that of the reference preparation. Comparative Example 1 is not similar to the reference preparation because the particle size of ursodeoxycholic acid is too small and the dissolution is too fast; Comparative Example 2 is not similar to the reference preparation because the particle size of ursodeoxycholic acid is too large, resulting in a slow dissolution rate. Comparative Examples 3-5 changed the process parameters of wet granulation, resulting in a cumulative dissolution that is not similar to the reference preparation. The ursodeoxycholic acid capsules of Comparative Examples 6-7, either because only xylitol is used or the mass ratio of corn starch and xylitol is changed, cannot exert a synergistic effect, resulting in a cumulative dissolution that is not similar to that of the reference preparation.

[0127] The above is a further description of the present invention in conjunction with specific embodiments, but these embodiments are merely exemplary and do not constitute any limitation on the scope of the present invention. It should be understood by those skilled in the art that the details and forms of the technical solution of the present invention may be modified or replaced without departing from the spirit and scope of the present invention, but these modifications and replacements all fall within the scope of protection of the present invention.

Claims

1. An ursodeoxycholic acid composition, characterized in that: The invention comprises the following ingredients by weight: 250 parts of ursodeoxycholic acid, 39-59 parts of corn starch, 18-28 parts of xylitol, 4-7 parts of colloidal silicon dioxide, 2-4 parts of magnesium stearate and 115-130 parts of purified water; The preparation method of the ursodeoxycholic acid composition comprises the following steps: S1. dissolving part of corn starch in part of purified water at a constant temperature to obtain a starch slurry; the part of purified water has been preheated to a fixed temperature; S2, mixing ursodeoxycholic acid, xylitol and remaining corn starch, adding remaining purified water, and then adding the starch slurry obtained in step S1 to granulate to obtain wet granules; S3, sieving and drying the wet granules obtained in step S2 to obtain dry granules, alternately sieving and granulating the dry granules and colloidal silicon dioxide, and then mixing with magnesium stearate to obtain an ursodeoxycholic acid composition; The granulation in step S2 has a water inlet rate of 0.5-1 L / s and a temperature of 20-30° C.; the starch slurry inlet rate is 1.7-6 L / s; The particle size of ursodeoxycholic acid in step S2 is 130-180 μm in D90 and 40-50 μm in D50; The mass ratio of the remaining corn starch and xylitol in step S2 is (1.2-1.8):

1.

2. The ursodeoxycholic acid composition according to claim 1, characterized in that The invention comprises the following ingredients by weight: 250 parts of ursodeoxycholic acid, 47.5 parts of corn starch, 25 parts of xylitol, 5 parts of colloidal silicon dioxide, 2 parts of magnesium stearate and 125 parts of purified water.

3. The ursodeoxycholic acid composition according to claim 1, characterized in that The constant temperature and the fixed temperature in step S1 are 80-90°C.

4. The ursodeoxycholic acid composition according to claim 1, characterized in that Supplied in capsule form.

5. The method for preparing the ursodeoxycholic acid composition according to any one of claims 1 to 4, characterized in that: The following steps are involved: S1. dissolving part of corn starch in part of purified water at a constant temperature to obtain a starch slurry; the part of purified water has been preheated to a fixed temperature; S2, mixing ursodeoxycholic acid, xylitol and remaining corn starch, adding remaining purified water, and then adding the starch slurry obtained in step S1 to granulate to obtain wet granules; S3, sieving and drying the wet granules obtained in step S2 to obtain dry granules, alternately sieving and granulating the dry granules and colloidal silicon dioxide, and then mixing with magnesium stearate to obtain an ursodeoxycholic acid composition.

6. The preparation method according to claim 5, characterized in that: In the granulation described in step S2, the stirring speed is 170-195 rpm and the cutting speed is 2000-2400 rpm.

7. Use of the ursodeoxycholic acid composition according to any one of claims 1 to 4 or the ursodeoxycholic acid composition prepared by the preparation method according to any one of claims 5 to 6 in the preparation of ursodeoxycholic acid preparations.

8. The use according to claim 7, characterized in that: The preparation is a capsule.

9. An ursodeoxycholic acid capsule, characterized in that: The ursodeoxycholic acid composition is prepared from the ursodeoxycholic acid composition according to any one of claims 1 to 4 or the ursodeoxycholic acid composition prepared by the preparation method according to any one of claims 5 to 6.

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